Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Wednesday, January 9, 2019 Daily Archives

Celltrion has confirmed its third biomanufacturing plant will be constructed in Korea after assessing locations overseas. The facility will have 120,000 L of biologics capacity. Seo Jeong-jin, chairman of Korean drugmaker Celltrion, told investors at last year’s JP Morgan Healthcare Conference that plans laid down in 2016 to build a third biomanufacturing facility at its site in Songdo, Incheon had been scrapped in favor of a much larger facility overseas. But a year on and Celltrion has announced a U-turn.…

Pall has established a Center of Excellence in Shanghai, China to service a biotech sector it says is worth $500 million and set to grow by double-digits. Bioprocessing vendor Pall has several centers of excellence (CoE) set up globally to showcase its biomanufacturing offerings and has now opened a center in Shanghai to service the Chinese market. “The goal of the CoE is to facilitate training and adoption of the advanced manufacturing technologies that will improve the productivity and robustness…